Sunitinib Malate Capsules Recalled Due to Label Mix-Up
AvKARE is recalling Sunitinib Malate 25 mg capsules nationwide due to a label mix-up in lot 100049501. The FDA has classified this as a Class II recall.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a prescription medication where label accuracy is critical to safe administration. Sunitinib Malate is a potent cancer drug, and a label mix-up represents a risk-of-harm to patients. No illnesses or injuries have been reported.
Plain-English summary
Sunitinib Malate Capsules, 25 mg are being recalled by AvKARE. The affected product is supplied in 28-count bottles with lot number 100049501 and an expiration date of 07/31/2026. Approximately 20 bottles have been distributed nationwide.
The recall was initiated due to a label mix-up. The FDA classified this as a Class II recall.
Patients or healthcare providers who have received medication matching this lot number should contact AvKARE or consult with their healthcare provider.
The recalled product
- Product
- SUNITINIB MALATE (SUNITINIB MALATE)
- Brand
- SUNITINIB MALATE
- Manufacturer
- AvKARE
- Category
- Drug — Prescription Medication
- Hazard
- label-mix-up
- mislabeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 100049501
- Exp. Date 07/31/2026
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · SUNITINIB MALATE
- HighPrescription Drug Sunitinib Malate Subject to Label Mix-Up Recall
FDA (Drugs) · 2024-12-11
- HighSunitinib Malate Capsules Recalled Due to Excess Moisture Content
FDA (Drugs) · 2023-07-19
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27